Section § 1320

Explanation

This section explains the reasons why the department can deny, suspend, or revoke licenses or registrations for clinical laboratories. It includes issues like dishonesty, breaking laws or regulations, allowing unqualified people to work unsupervised, using false credentials, and misrepresenting lab capabilities. It also covers violations connected to public health and safety, false reporting, and unprofessional behavior. Licenses can also be revoked for drug or alcohol misuse that affects job performance, failure to cooperate with inspections, and not complying with disease reporting rules.

The department may deny, suspend, or revoke any license or registration issued under this chapter for any of the following reasons:
(a)CA Business & Professions Code § 1320(a) Conduct involving moral turpitude or dishonest reporting of tests.
(b)CA Business & Professions Code § 1320(b) Violation by the applicant, licensee, or registrant of this chapter or any rule or regulation adopted pursuant thereto.
(c)CA Business & Professions Code § 1320(c) Aiding, abetting, or permitting the violation of this chapter, the rules or regulations adopted under this chapter or the Medical Practice Act, Chapter 5 (commencing with Section 2000) of Division 2.
(d)CA Business & Professions Code § 1320(d) Permitting a licensed trainee to perform tests or procure specimens unless under the direct and responsible supervision of a person duly licensed under this chapter or physician and surgeon other than another licensed trainee.
(e)CA Business & Professions Code § 1320(e) Violation of any provision of this code governing the practice of medicine and surgery.
(f)CA Business & Professions Code § 1320(f) Proof that an applicant, licensee, or registrant has made false statements in any material regard on the application for a license, registration, or renewal issued under this chapter.
(g)CA Business & Professions Code § 1320(g) Conduct inimical to the public health, morals, welfare, or safety of the people of the State of California in the maintenance or operation of the premises or services for which a license or registration is issued under this chapter.
(h)CA Business & Professions Code § 1320(h) Proof that the applicant or licensee has used any degree, or certificate, as a means of qualifying for licensure that has been purchased or procured by barter or by any unlawful means or obtained from any institution that at the time the degree, certificate, or title was obtained was not recognized or accredited by the department of education of the state where the institution is or was located to give training in the field of study in which the degree, certificate, or title is claimed.
(i)CA Business & Professions Code § 1320(i) Violation of any of the prenatal laws or regulations pertaining thereto in Chapter 2 (commencing with Section 120675) of Part 3 of Division 105 of the Health and Safety Code and Article 1 (commencing with Section 1125) of Group 4 of Subchapter 1 of Chapter 2 of Part 1 of Title 17 of the California Code of Regulations.
(j)CA Business & Professions Code § 1320(j) Knowingly accepting an assignment for clinical laboratory tests or specimens from and the rendering of a report thereon to persons not authorized by law to submit those specimens or assignments.
(k)CA Business & Professions Code § 1320(k) Rendering a report on clinical laboratory work actually performed in another clinical laboratory without designating clearly the name and address of the laboratory in which the test was performed.
(l)CA Business & Professions Code § 1320(l) Conviction of a felony or of any misdemeanor involving moral turpitude under the laws of any state or of the United States arising out of or in connection with the practice of clinical laboratory technology. The record of conviction or a certified copy thereof shall be conclusive evidence of that conviction.
(m)CA Business & Professions Code § 1320(m) Unprofessional conduct.
(n)CA Business & Professions Code § 1320(n) The use of drugs or alcoholic beverages to the extent or in a manner as to be dangerous to a person licensed under this chapter, or any other person to the extent that that use impairs the ability of the licensee to conduct with safety to the public the practice of clinical laboratory technology.
(o)CA Business & Professions Code § 1320(o) Misrepresentation in obtaining a license or registration.
(p)CA Business & Professions Code § 1320(p) Performance of, or representation of the laboratory as entitled to perform, a clinical laboratory test or examination or other procedure that is not within the specialties or subspecialties, or category of laboratory procedures authorized by the license or registration.
(q)CA Business & Professions Code § 1320(q) Refusal of a reasonable request of HCFA, a HCFA agent, the department, or any employee, agent, or contractor of the department, for permission to inspect, pursuant to this chapter, the laboratory and its operations and pertinent records during the hours the laboratory is in operation.
(r)CA Business & Professions Code § 1320(r) Failure to comply with reasonable requests of the department for any information, work, or materials that the department concludes is necessary to determine the laboratory’s continued eligibility for its license or registration, or its continued compliance with this chapter or the regulations adopted under this chapter.
(s)CA Business & Professions Code § 1320(s) Failure to comply with a sanction imposed under Section 1310.
(t)CA Business & Professions Code § 1320(t) Failure to comply with the disease reporting requirements adopted pursuant to Section 120130 of the Health and Safety Code. However, when a laboratory is not able to obtain complete information for a patient within the reporting timeframes, it shall document that it made a good faith effort to do so and it shall submit the report with the available information within the required reporting timeframes and, in that case, the laboratory shall not be subject to sanctions for failure to submit complete patient information.

Section § 1321

Explanation

This law defines what a 'conviction' means within its chapter. It includes pleas or verdicts of guilty and convictions from a plea of 'nolo contendere' (a plea where the defendant does not admit guilt but accepts punishment). The state can choose to deny, revoke, or suspend a professional license if enough time has passed for any appeals or if the conviction has been confirmed. Even if, later on, the person is allowed to withdraw their guilty plea or their conviction is set aside, this doesn't change the ability to deny or revoke a license. However, the authorities must also consider any evidence showing that the person has been rehabilitated.

For purposes of this chapter, a conviction means a plea or verdict of guilty or a conviction following a plea of nolo contendere. An action to deny, revoke, or suspend the license or registration may be taken when the time for appeal has elapsed or the judgment of conviction has been affirmed on appeal or when an order granting probation is made suspending the imposition of a sentence, notwithstanding a subsequent order pursuant to Section 1203.4 of the Penal Code permitting withdrawal of a plea of guilty, or setting aside a verdict of guilty or dismissing the accusation, information, or indictment. The director shall take into account all competent evidence or rehabilitation furnished.

Section § 1322

Explanation
This law states that if a professional license or registration is going to be suspended or taken away, the process must follow certain rules laid out in another legal section, specifically Section 100171 of the Health and Safety Code.
The proceedings under this chapter for the suspension or revocation of a license or registration shall be conducted in accordance with Section 100171 of the Health and Safety Code.

Section § 1323

Explanation

This law allows a department to put a temporary halt on someone's license or registration if they think it's necessary for public safety, even before a formal hearing. They must notify the person affected and tell them why. Once the person responds with a notice that they want to defend themselves, a hearing must take place within 15 days and happen within 30 days at the latest. The suspension stays until a decision is made after the hearing. If no decision is made within 60 days after the hearing, the suspension is automatically lifted.

The department may temporarily suspend a license or registration prior to any hearing, when it has determined that the action is necessary to protect the public welfare. The department shall notify the licensee or registrant of the temporary suspension and the effective date thereof and at the same time shall serve the licensee or registrant with an accusation. Upon receipt of a notice of defense by the licensee or registrant, the matter shall, within 15 days, be set for hearing. The hearing shall be held as soon as possible, but not later than 30 days after receipt of that notice. The temporary suspension shall remain in effect until the time the hearing is completed and the department has made a final determination on the merits. However, the temporary suspension shall be deemed vacated if the department fails to make a final decision within 60 days after the hearing has been completed.

Section § 1324

Explanation

If a clinical laboratory's license or registration was revoked, the owner or operator can't own or run another lab with a license for two years after the revocation, unless their license was revoked automatically under a different specific section.

Except for a person or entity whose license was revoked automatically under Section 1265, no person or entity who has owned or operated a clinical laboratory that had its license or registration revoked may, within two years of the revocation of the license or registration, own or operate a laboratory for which a license or registration has been issued under this chapter.

Section § 1325

Explanation

If a clinical laboratory is banned from participating in the Medicare or Medicaid programs, or if its certification is revoked under CLIA, its license in California will be automatically suspended for the same period that the ban or revocation lasts.

Notwithstanding Sections 1267 and 1322, the license or registration of a clinical laboratory that has been excluded from participation under the Medicare program (Title XVIII of the Social Security Act (42 U.S.C. Sec. 1395 et seq.)), under the Medicaid Program (Title XIX of the Social Security Act (42 U.S.C. Sec. 1396 et seq.)), or that had its certificate revoked under CLIA, shall be automatically suspended by the department for the period the laboratory is so excluded or has its certificate revoked.

Section § 1326

Explanation

This law allows the department to go to court to stop someone from breaking rules related to the chapter it governs. They don't have to prove that no other solutions could fix the issue or that it would cause significant harm. If the court agrees that the rules were broken, it will order the violator to stop.

The department may bring an action to enjoin the violation or threatened violation of this chapter or the regulations adopted pursuant thereto in the superior court in and for the county in which the violation occurred or is about to occur. Any proceeding under this section shall conform to the requirements of Chapter 3 (commencing with Section 525) of Title 7 of Part 2 of the Code of Civil Procedure, except that the department shall not be required to allege facts necessary to show or tending to show lack of adequate remedy at law or irreparable damage or loss. With respect to any action brought pursuant to this action alleging actual violation of this chapter or the regulations adopted pursuant thereto, the court shall, if it finds the allegations to be true, issue its order enjoining the discontinuance of the violation.

Section § 1327

Explanation

This law says that a department in California can work together with the federal Secretary of Health and Human Services. They can make agreements to use the department's services or facilities to help implement the provisions of the Clinical Laboratory Improvement Amendments (CLIA).

The department may enter into agreements with the Secretary of Health and Human Services for the use of the services or facilities of the department for carrying out the provisions of CLIA.